Patients with type 1 diabetes need to monitor their blood glucose levels multiple times a day, about 40 percent of children use a continuous glucose monitor (CGM), with insulin being delivered through a pump or by injection to regulate these levels.
Emerging technologies that provide a ‘Do It Yourself’ approach are changing the way some people manage this disease.
People can build their own ‘hybrid closed loop’ system using open source software – software for which the original source code is made freely available. This provides access to real-time continuous glucose monitoring data via a personal website or smartphone.
In Australia, software can be listed as a medical device if it undergoes a review of its safety and effectiveness by experts. The TGA fee for a Class III device is around $A100,000, but developers of the software aren’t in a position to pay this.
While it’s unknown exactly how many people are using DIY open-source technology in Australia, we know from the University of Melbourne study that it is being used by parents for their children.
Although there may be concerns about legal liability and medical indemnity, it’s important that a therapeutic relationship is maintained with parents to enable the ongoing care of the child.
Tego Insurance – Supporting Doctors in Practice
The gap between regulation and good practice are important considerations. If the software was regulated as a medical device, then this may have an impact on how insurance may respond to these exposures.
As Australian medical indemnity Insurance providers, we cover your practice with medical indemnity insurance, GP medical indemnity insurance, doctors indemnity insurance, medical malpractice insurance, medical practice insurance, and more. If you are a health practitioner with Tego, your medical indemnity insurance comes with 24/7 medico-legal advice and support to guide you through the risks of healthcare IoT devices
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